1. Technical Field
The present invention relates to containers for pharmaceutical materials, particularly for a powdered pharmaceutical that must be reconstituted by thorough mixing with a specific quantity of a diluent prior to administering it.
2. Related Background Art
Reconstitution of powdered pharmaceuticals is a daily task in most pharmacies. Patients who have difficulty swallowing medication in the form of a capsule or tablet benefit from the availability of the medication in a liquid suspension. Such prescriptions are ordered by physicians with instructions to reconstitute a prescribed strength of powdered pharmaceutical with a prescribed volume of diluent, typically water. In the pharmacy, glass or plastic graduated cylinders are used to manually measure the diluent that is gradually added to the powdered pharmaceutical. In many pharmacies, the reconstitution is accomplished manually by measuring the diluent from a presumably sterile internal source using conventional lab ware, then adding the liquid to the container containing the powdered pharmaceutical and mixing the suspension by shaking the container.
Commercial reconstitution devices are available. These devices consist of a diluent storage unit that holds 1-5 gallons of water and is usually placed on a high shelf. The diluent is gravity fed through a computer-controlled valving system driven by a scanned bar code or other identification means to the container containing the powdered pharmaceutical. The diluent is added in two or more portions to allow prewetting of the dry powder to avoid the formation of unsuspended clumps of powder.
Even when using the latest automated systems, accuracy and sterility can be issues. A better solution is to provide the diluent as a premeasured, prepackaged sterile component that can then be mixed with the powdered pharmaceutical through an integrated packaging system that maintains accuracy and sterility.
Multiple compartment containers that allow mixing of components stored separately in each compartment upon tearing or bursting a frangible membrane are known in the art. Such containers have been developed for the delivery of flavored beverages or other food products, and for the preparation of sterile medical products wherein the product has a limited lifetime in mixed form, but much longer shelf life when stored as separate components. In the case of retail pharmaceuticals, it is preferred that the mixing process be accomplished by trained individuals to ensure that a mixture of adequate uniformity and potency is delivered to the patient. Furthermore, it is preferred that the packaging be capable of delivering the diluent to the powdered pharmaceutical in two or more portions to allow prewetting, as described above. The multiple compartment containers known in the art do not generally support these preferences.
There is a need for a new means to mix pharmaceuticals that provides for pre-measured sterile components and allows pre-wetting of dry components.